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NCT01169363 Clinical Trial

Biomarkers in Bone Marrow and Blood Samples From Older Patients With Acute Myeloid Leukemia Treated With Cytarabine-Based Therapy

Leukemia Clinical Trial

Official title:
Validation of AML Proteomic Signature Associated With Clinical Response to Ara-C Based Induction Therapy in Patients 60 Years of Age or Older Using Samples From ECOG Studies 3999, 3993 and 1490

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01169363
Other study ID # CDR0000681533
Secondary ID ECOG-E1L09T1
Status Completed
Phase N/A
First received July 23, 2010
Last updated May 16, 2017
Start date July 8, 2010
Est. completion date August 8, 2010

Study information
Verified date May 2017
Source Eastern Cooperative Oncology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

RATIONALE: Studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.

Description:

OBJECTIVES:

Primary

- To validate a pre-specified proteomic classifier to predict the likelihood of complete response (CR) to cytarabine-based induction chemotherapy in older patients with non-M3 acute myeloid leukemia.

Secondary

- To identify signaling nodes associated with risk of relapse among these patients who achieve a CR to induction chemotherapy.

OUTLINE: This is a multicenter study.

Previously collected bone marrow and peripheral blood samples are analyzed to validate the association of a pre-specified proteomic signature with clinical response via flow cytometry.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date August 8, 2010
Est. primary completion date August 8, 2010
Accepts healthy volunteers No
Gender All
Age group 60 Years to 120 Years
Eligibility DISEASE CHARACTERISTICS:

- Treated on EST-1490, E-3993, or ECOG-E3999

- Bone marrow and peripheral blood samples collected at diagnosis and before induction chemotherapy available

- No M3 disease

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• proteomic profiling

Other:
• flow cytometry

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
ECOG-ACRIN Cancer Research Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients achieving a complete response to induction chemotherapy 1 month
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